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Early Antenatal Support for Iron Deficiency Anemia (EASI-A)

Primary Purpose

Pregnancy Related, Anemia, Iron Deficiency, Anemia of Pregnancy

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Ferumoxytol

Ferrous Sulfate

About this trial

This is an interventional treatment trial for Pregnancy Related

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Singleton gestation
Gestational age <24 weeks
Baseline Hb ≥9.0 and <11.0 with evidence of iron deficiency anemia

Iron deficiency anemia diagnosed (at any point in patient history) by:

Hb<11.0
Ferritin<30 and/or total iron saturation <20

Exclusion Criteria:

Sickle cell Disease (NOT sickle cell trait)
Evidence of acute anemia requiring transfusion or IV iron therapy
Major congenital or chromosomal anomaly
Previous use of IV iron in this pregnancy
Severe cardiac, renal, or liver disease
Autoimmune disease (ie Systemic Lupus Erythematosus (SLE)
Allergy or contraindication to either study drug
History of medication allergy, reaction to IV infusion, or reaction to Feraheme or other IV iron products

Sites / Locations

Thomas Jefferson University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Oral Iron

Intravenous Iron

Arm Description

325mg oral iron (ferrous sulfate) twice daily

510mg ferumoxytol intravenous infusion for two doses total; second dose 3-8 days after first dose.

Outcomes

Primary Outcome Measures

Change in Hemoglobin

Change in hemoglboin at day 90 following treatment initiation

Secondary Outcome Measures

Anemia resolution

Percent of participants in each group with Hb>=11.0 at day 90

Anemia at Delivery

Percent of participants in each group with Hb>=11.0 at delivery

Need for additional therapy

Percent of participants in each group requiring additional therapy for iron deficiency anemia after 28 weeks

Quality of life scale

Linear Analogue Scale Assessment

Adherence

adherence to assigned group. Measured by what % of IV infusions completed of the two required in IV iron group, and for oral iron group, what %pills taken/prescribed based on pill counts

Need for post partum transfusion

Incidence of transfusion after delivery/post partum

Neonatal outcomes: cord blood iron indices

Hb, ferritin, total iron saturation

Neonatal outcomes: birth weight

birth weight (grams)

Neonatal outcomes gestational age of delivery (weeks)

gestational age of delivery (weeks)

Full Information

NCT ID

NCT04278651

First Posted

February 4, 2020

Last Updated

February 4, 2022

Sponsor

Thomas Jefferson University

Collaborators

Auerbach Hematology and Oncology

1. Study Identification

Unique Protocol Identification Number

NCT04278651

Brief Title

Early Antenatal Support for Iron Deficiency Anemia

Acronym

EASI-A

Official Title

Early Antenatal Support for Iron Deficiency Anemia: A Randomized Controlled Trial of Early Initiation of Intravenous Versus Oral Iron Therapy for Treatment of Iron Deficiency Anemia in Pregnancy

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 29, 2021 (Actual)

Primary Completion Date

August 30, 2023 (Anticipated)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Thomas Jefferson University

Collaborators

Auerbach Hematology and Oncology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a randomized, controlled multi-site trial of iron therapy in pregnancy. The purpose of this research is to see if second trimester initiation of intravenous (IV) iron therapy is better than oral iron therapy for treatment of anemia in pregnancy by improving blood count, quality of life and reducing side effects.

Detailed Description

Pregnant singletons diagnosed with iron deficiency anemia will be enrolled between 14-24 weeks and will be randomized 1:1 to either a course of ferumoxytol (510mg x 2 doses 3-8 days apart) or oral iron (325mg) twice daily.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pregnancy Related, Anemia, Iron Deficiency, Anemia of Pregnancy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Randomized controlled trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Oral Iron

Arm Type

Active Comparator

Arm Description

325mg oral iron (ferrous sulfate) twice daily

Arm Title

Intravenous Iron

Arm Type

Experimental

Arm Description

510mg ferumoxytol intravenous infusion for two doses total; second dose 3-8 days after first dose.

Intervention Type

Drug

Intervention Name(s)

Ferumoxytol

Intervention Description

510mg infusion x 2 doses 3-8 days apart

Intervention Type

Drug

Intervention Name(s)

Ferrous Sulfate

Intervention Description

325mg oral twice daily

Primary Outcome Measure Information:

Title

Change in Hemoglobin

Description

Change in hemoglboin at day 90 following treatment initiation

Time Frame

90 days

Secondary Outcome Measure Information:

Title

Anemia resolution

Description

Percent of participants in each group with Hb>=11.0 at day 90

Time Frame

90 days

Title

Anemia at Delivery

Description

Percent of participants in each group with Hb>=11.0 at delivery

Time Frame

9 months

Title

Need for additional therapy

Description

Percent of participants in each group requiring additional therapy for iron deficiency anemia after 28 weeks

Time Frame

9 months

Title

Quality of life scale

Description

Linear Analogue Scale Assessment

Time Frame

30, 60, 90 days

Title

Adherence

Description

adherence to assigned group. Measured by what % of IV infusions completed of the two required in IV iron group, and for oral iron group, what %pills taken/prescribed based on pill counts

Time Frame

90 days

Title

Need for post partum transfusion

Description

Incidence of transfusion after delivery/post partum

Time Frame

9 months

Title

Neonatal outcomes: cord blood iron indices

Description

Hb, ferritin, total iron saturation

Time Frame

9 months

Title

Neonatal outcomes: birth weight

Description

birth weight (grams)

Time Frame

9 months

Title

Neonatal outcomes gestational age of delivery (weeks)

Description

gestational age of delivery (weeks)

Time Frame

9 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Singleton gestation Gestational age <24 weeks Baseline Hb ≥9.0 and <11.0 with evidence of iron deficiency anemia Iron deficiency anemia diagnosed (at any point in patient history) by: Hb<11.0 Ferritin<30 and/or total iron saturation <20 Exclusion Criteria: Sickle cell Disease (NOT sickle cell trait) Evidence of acute anemia requiring transfusion or IV iron therapy Major congenital or chromosomal anomaly Previous use of IV iron in this pregnancy Severe cardiac, renal, or liver disease Autoimmune disease (ie Systemic Lupus Erythematosus (SLE) Allergy or contraindication to either study drug History of medication allergy, reaction to IV infusion, or reaction to Feraheme or other IV iron products

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rupsa C Boelig, MD

Phone

215-955-9196

rupsa.boelig@jefferson.edu

Facility Information:

Facility Name

Thomas Jefferson University Hospital

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rupsa C Boelig, MD

rupsa.boelig@jefferson.edu

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

After completion of planned primary and secondary analysis, IPD data may be available on request with completion of appropriate data sharing agreements

IPD Sharing Time Frame

1 year after publication of study results

IPD Sharing Access Criteria

After completion of planned primary and secondary analysis, IPD data may be available on request with completion of appropriate data sharing agreements

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Early Antenatal Support for Iron Deficiency Anemia

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